BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REBOUND HRD

    MDR report key: 6640527 · Received June 14, 2017

    Report

    Report Number
    3005770977-2017-00003
    Event Type
    Malfunction
    Date Received
    June 14, 2017
    Date of Event
    February 20, 2017
    Report Date
    June 13, 2017
    Manufacturer
    ARB MEDICAL, LLC
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SEPARATED FRAME OF THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420083 REBOUND HRD HERNIA EPAIR DEVICE FTL ARB MEDICAL, LLC RB-SLD-LSO-PP 150021

    Patients

    Seq Age Sex Outcome Treatment
    1 Other